Label: MICROFIT CUSHION 201- titanium dioxide, octinoxate, octisalate powder
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Contains inactivated NDC Code(s)
NDC Code(s): 71786-030-01, 71786-030-02 - Packager: Codecosme International Co., Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated October 18, 2017
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
Inactive ingredients: Bambusa Vulgaris Water, Cyclopentasiloxane, Trimethylsiloxysilicate, Butylene Glycol Dicaprylate/Dicaprate, PEG-8 Dimethicone, Pentylene Glycol, Methyl Methacrylate Crosspolymer, Butylene Glycol, Glycerin, Niacinamide, Mica (CI 77019), Dimethicone, Iron Oxides (CI 77492), Silica, Cetyl PEG/PPG-10/1 Dimethicone, Dipropylene Glycol, Magnesium Sulfate, Phenoxyethanol, Caprylyl Methicone, Dimethicone/Vinyl Dimethicone Crosspolymer, Diphenyl Dimethicone, Fragrance(Parfum), Water, Stearic Acid, Alumina, Disteardimonium Hectorite, Triethoxycaprylylsilane, Iron Oxides (CI 77491), Aluminum Hydroxide, Ethylhexylglycerin, Iron Oxides (CI 77499), Adenosine, Disodium EDTA, Calcium Carbonate, Polymethylsilsesquioxane, Gossypium Herbaceum (Cotton) Powder, Caprylic/Capric Triglyceride, Lecithin, Polyglutamic Acid, Cassia Angustifolia Seed Polysaccharide, Phospholipids, Ceramide NP, 1,2-Hexanediol, Cholesterol, Arginine, Phytosterols
- PURPOSE
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WARNINGS
Warnings: 1. If any of the following symptoms occur when using the product, stop using immediately and consult a dermatologist. a) red spots, swelling, itchy rashes other skin irritations, etc. b) if a) occurs after applying and being exposed to sunlight. 2. Do not use on wounds, inflamed skin, itchy areas, or other infected areas. 3. Storage and handling: a) must close cap after use. b) Keep out of reach of children. c) keep away from extreme heat, cold and direct sunlight. d) Avoid contact with eyes. In case of contact with eyes, rinse thoroughly with water. 4. For external use only.
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DESCRIPTION
Uses: An ultra-light and non-oxidizing cushion foundation that allows layering without caking. Perfect for mid-day touch ups.
Directions: 1. Gently soak the applicator puff on to mesh to use product. 2. Start from inner areas of the face and work outwards 3. Softly swipe over the skin to spread evenly before applying the foundation. * Coverage can build up by layering a small amount several times. 4. Close cap after use. 5. To refill the product: Open outer cap, but close the inner cap and flip over the product. While holding the product push down on the bottom sticker with both thumbs while having outer cap open. Once the existing container is removed, replace it with a refill with the hinge set on the dipped area which is on the left hand side.
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
MICROFIT CUSHION 201
titanium dioxide, octinoxate, octisalate powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71786-030 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide 1.15 g in 12 g Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) Octinoxate 0.80 g in 12 g Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate 0.48 g in 12 g Inactive Ingredients Ingredient Name Strength Butylene Glycol (UNII: 3XUS85K0RA) PEG-8 Dimethicone (UNII: GIA7T764OD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71786-030-02 1 in 1 CARTON 10/01/2017 1 NDC:71786-030-01 12 g in 1 CONTAINER; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 10/01/2017 Labeler - Codecosme International Co., Ltd. (689846614) Registrant - Codecosme International Co., Ltd. (689846614) Establishment Name Address ID/FEI Business Operations Cosmecca Korea Co., Ltd. 688830827 manufacture(71786-030)
